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[World Medical Association (AMM). Helsinki Declaration. Ethical principles for medical research involving human subjects].

The role of nurses in the Clinical Ethic Committees (ECs) was discussed in a seminar organised by Assistenza Infermieristica e Ricerca and the Mario Negri Research Institute. A recent Italian law of 1998 regulates the functioning and the composition of the local ECs, where at least a nurse must be present. The actual and potential role of the nurses has been discussed from different points of view with and by other professions represented in ECs. Few model experiences were presented by nurses member of ECs. Based on these contributions an important discussion developed, which led to the identification of the main areas of interest and of the key priorities for the development of a more active involvement of nurses in issues specifically related to informed consent, prospective monitoring of the trial implementation, continuity of care across experimental protocols and routine practices. The main contributions to the seminar are reported, together with proposal for developing a specific nursing culture and practice to ECs and clinical trials.

Ethics↗
PubMed2002

[Points of view in comparison on the 5ht revision of the Declaration of Helsinki].

The horror for the scientific crimes of the nazi period led the World Medical Association (WMA), in 1964, to settle by the Helsinki declaration, an ethical code for the medical research on human beings. The code was successively modified in order to account for the developments of the medical science in the past decades. In October 2000, the last revision, the 5th one, has been approved in Edinburgh. Its preparation lasted three years and entailed a passionate, but also profitable dispute between who believes that ethical principles must be followed even though they can hamper the scientific progress, and who thinks that more articulate evaluations should prevail. The initial victory of the more intransigent party resulted in the maintenance of the norm which entails the greatest restriction in using placebo, but, after one year and half, it was partially reshaped by a more permissive interpretation of the same WMA, while waiting for a new revision that is scheduled for this year.

Clinical Trials as Topic↗